Prescribed Reading: All the approvals
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Sanofi talks marketing for Dupixent.
- Senators launch investigation into opioid crisis.
- Depomed gives in to activist investors.
It was a big week at the Food and Drug Administration. The regulatory agency OK’d three potential blockbusters and saved another blockbuster from the threat of generic competition.
The FDA kickstarted the week on Monday with its approval of Tesaro’s PARP inhibitor Zejula (niraparib), three months ahead of its user fee action date. The drug is now set to compete with AstraZeneca’s Lynparza (olaparib) and Clovis Oncology’s Rubraca (rucaparib), both already approved PARP inhibitors. Even though Tesaro is the last entry to market, it has a distinct advantage over its competition – it has the broadest label. The FDA greenlit the drug for use in those patients with or without the BRCA mutation; the other PARP inhibitors are currently only approved for those patients that have the mutation.
The Tesaro ruling was followed up the next day by the approval of Sanofi and Regeneron’s atopical dermatitis drug Dupixent (dupilumab). The eczema treatment is the second approval for the partnership behind the cholesterol drug Praluent (alirocumab). While Praluent has been a bit of a letdown for the pair, Dupixent holds much greater promise and could be what both companies need.
Later that night the FDA gave the go-ahead to the highly anticipated multiple sclerosis drug Ocrevus (ocrelizumab). Roche garnered an approval for both the relapsing form of the disease as well as the primary progressive form. Ocrevus is the first drug approved to treat the rarer form of the disease and could give Roche a much easier chance of pushing into the secondary progressive MS market as well.
On Wednesday, the regulatory agency put the kibosh on Mylan’s generic version of GlaxoSmithKline’s best-selling respiratory treatment Advair (fluticasone/salmeterol). While generic competition for the blockbuster may not be far off, GSK gets a short reprieve. The British pharma expects revenues from the asthma treatment will decline by more than 45% once generics enter the market.
Mergers & analysis
In the wake of all of the FDA approvals this week, drug pricing has become top of mind once again (not that it was ever really out of our thoughts).
Sanofi and Regeneron priced their new eczema drug at $37,000 per year, per patient. While it sounds like a steep price, it’s likely a lot lower than shareholders would like, but Express Scripts’ Steve Miller admitted to Forbes that it’s higher than the pharmacy benefit manager would prefer. Therefore, it’s the perfect compromise.
Roche took a similar route, pricing its new MS drug at a 20% discount to the overage price of other MS treatments – placing the therapy at $65,000 annually per patient. The Institute for Clinical and Economic Review (ICER) recently released a report accusing MS drugs of being priced too high. ICER is definitely right, especially considering the number of competitors in the MS market – Sanofi, Roche, Novartis and Biogen, to name a few. While Ocrevus is only priced incrementally lower than the other already-marketed treatments, it could be the first step in a better direction.
Industry lobbying group PhRMA continues to defend drugmakers and the innovation they provide, most recently releasing a report pushing the blame on to pricing middlemen like insurers and pharmacy benefit managers.
Karyopharm got some good news on Thursday when the Food and Drug Administration allowed the biotech to move forward with a study of its lead candidate selinexor after lifting a clinical hold. The hold was put in place a couple weeks ago and was due to administrative issues — not safety problems — with the drug.
Meanwhile, Vertex Pharmaceuticals pleased investors with positive data for its cystic fibrosis combination. The company now intends to file for approval of the combo drug in both the U.S. and EU during the third quarter. Data from the late-stage studies suggest the treatment, a pairing of Vertex's Kalydeco (ivacaftor) with a second-generation corrector known as tezacaftor, will be a strong follow-on for the company’s portfolio.
While the data was good news for the Boston biotech, other news reports show that Vertex has been making cuts to staff and shuttering sites. Reports indicate that Vertex closed its Canada research site to consolidate R&D across three other sites.
While clinical news was good this week, investors are looking ahead to the American Association for Cancer Research (AACR) annual meeting set to begin this weekend. The conference will include updates from Bristol-Myers Squibb, Kite Pharma and Incyte, amongst others. Stay tuned to BioPharma Dive for updates from the meeting.
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